HI-TORQUE POWERTURN 1044594Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648173974), received between Feb 26, 2019 and Aug 18, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT HAS BEEN REPORTED THE PROCEDURE WAS IN THE SUBCLAVIAN VEIN WITH NO STENOSIS OR TORTUOSITY. THE HI-TORQUE 014 BHW HYDRO 190CM GUIDE WIRE AND THE HT POWERTURN 190CM GUIDE WIRE COULD NOT BE SEEN DURING PROCEDURE. THE RADIOPACITY TIP MARK OF BOTH GUIDE WIRES COULD NOT BE VISUALIZED. ANOTHER HT BHW GUIDE WIRE WAS USED IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574714 ↗
• MalfunctionJun 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 100% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A POWERTURN GUIDE WIRE (GW) WAS ADVANCED TO THE LESION WITHOUT ISSUE, AND AN OPTICAL COHERENCE TOMOGRAPHY (OCT) CATHETER WAS ADVANCED OVER THE GW TO THE LESION WITHOUT ISSUE. THE PROCEDURE WAS PERFORMED WITHOUT ISSUE. THE OCT CATHETER AND POWERTURN GW WERE REMOVED TOGETHER, WITHOUT RESISTANCE. AFTER REMOVAL OF THE POWERTURN FROM THE OCT CATHETER, IT WAS NOTED THAT THE TIP OF THE GW HAD SEPARATED AND REMAINED IN THE OCT CATHETER. THERE WAS NO PART OF ANY DEVICE REMAINING IN THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED AT THAT POINT SO NO REPLACEMENT DEVICES WERE REQUIRED. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110899 ↗
• InjuryFeb 26, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. WHILE ADVANCING THE HI-TORQUE POWERTURN GUIDE WIRE TO THE VESSEL, THE WIRE JUMPED FORWARD, STRAIGHTENING THE VESSEL AND DISSECTING IT NEAR THE PROXIMAL RIGHT OSTIAL. PATIENT WAS SENT TO SURGERY FOR SUCCESSFUL REPAIR. THE PATIENT WAS REPORTED DOING FINE AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8372173 ↗